Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: the Cleveland Cardiometabolic Cohort

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test

• Provides written informed consent and is capable of reading and comprehending the informed consent

• Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped \>6 months prior to study entry

• Is planning on starting antiretroviral therapy as part of routine clinic care

Locations
United States
Ohio
University Hospitals Case Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Danielle Labbato, BSN
danielle.labbato@uhhospitals.org
216-844-2739
Backup
Grace McComsey, MD
mccomsey.grace@clevelandactu.org
Time Frame
Start Date: 2016-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
HIV-infected ART-naïve
HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen
Related Therapeutic Areas
Sponsors
Leads: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov